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Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Theradex
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025688
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: carboplatin
Drug: paclitaxel
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed Description:

OBJECTIVES:

  • Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.
  • Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.
  • Compare the safety of these regimens in this patient population.
  • Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
  • Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks.

Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course during study, and then after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Must have clinical evidence of stage IV (M1) disease
  • HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown
  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Patients with bone-only disease are not eligible
  • Ineligible if currently experiencing a complete or partial response to prior hormonal therapy
  • Patients with disease progression after prior response to hormonal therapy are eligible
  • Disease progression without prior hormonal therapy is allowed
  • Stable or asymptomatic brain metastasis allowed if:

    • Other measurable disease exists
    • Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Pre- or post-menopausal

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 2 times ULN
  • Corrected calcium less than 12 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No documented myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmia

Other:

  • No active serious infection
  • No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
  • No clinically significant (greater than grade 1) peripheral neuropathy
  • No other serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation
  • More than 6 months since prior adjuvant monoclonal antibody therapy
  • More than 6 months since prior adjuvant vaccine therapy
  • No prior trastuzumab (Herceptin)
  • No concurrent anticancer immunotherapy

Chemotherapy:

  • No prior chemotherapy for metastatic breast cancer
  • More than 6 months since prior adjuvant high-dose chemotherapy
  • More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy
  • Prior adjuvant taxanes allowed only if administered every 3 weeks

Endocrine therapy:

  • See Disease Characteristics
  • Any number of prior hormonal therapies for metastatic breast cancer allowed

    • Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy
  • No concurrent anticancer hormonal agents (including megestrol)

Radiotherapy:

  • At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)
  • No prior radiotherapy to 30% or more of bone marrow
  • No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease

Surgery:

  • At least 3 weeks since prior major surgery

Other:

  • More than 6 months since prior neoadjuvant therapy
  • No other concurrent anticancer drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025688

  Hide Study Locations
Locations
United States, Arkansas
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
United States, California
Monterey Bay Oncology
Monterey, California, United States, 93940
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States, 91767-3021
United States, Connecticut
New Britain General Hospital
New Britain, Connecticut, United States, 06050
United States, Florida
Cancer Research Network, Inc.
Hollywood, Florida, United States, 33020
Center for Hematology and Oncology
Boca Raton, Florida, United States, 33486
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
MacNeal Cancer Center
Berwyn, Illinois, United States, 60402
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21236
United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Finger Lakes Community Cancer Center
Clifton Springs, New York, United States, 14432
United States, Ohio
Clinical Hematology & Oncology Service, Inc.
Akron, Ohio, United States, 44302
United States, Pennsylvania
Scranton Hematology-Oncology
Scranton, Pennsylvania, United States, 18510
United States, Tennessee
East Tennessee Oncology/Hematology, P.C.
Knoxville, Tennessee, United States, 37920
West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Oncology Consultants
Houston, Texas, United States, 77024
Scott and White Clinic
Temple, Texas, United States, 76508
Texas Cancer Care
Fort Worth, Texas, United States, 76104
United States, Virginia
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Dean Medical Center
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068992, THERADEX-B00-1370, BMS-TAX/MEN.13
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025688     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009